Clinical trials: Trastuzumab
- Drug or intervention Trastuzumab
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy Male Participants
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
- Trial name
- NCT07299955
- Testing
- Bmab3000, Herceptin Hylecta®
- Where
- New Zealand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK PLC
Breast Neoplasm
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
- Trial name
- NCT03013881
- Testing
- UB-921, Herceptin
- Where
- Taiwan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- United BioPharma
Metastatic Breast Cancer, Metastatic Gastric Cancer
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells.
- Trial name
- NCT05765357
- Testing
- Trastuzumab for injection, Herceptin
- Where
- China
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent…
- Trial name
- NCT07495930
- Testing
- HLX319, EU-Phesgo
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
- Trial name
- NCT02075073
- Testing
- SB3, EU sourced Herceptin®, US sourced Herceptin®
- Where
- Germany
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Healthy Volunteers
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
This is a double-blind, two-arm, parallel-group, single-dose study.
- Trial name
- NCT02665637
- Testing
- Trastuzumab
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy Volunteer
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Trial name
- NCT02100917
- Testing
- DMB-3111, trastuzumab
- Where
- Japan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers
- Trial name
- NCT03912441
- Testing
- BCD-147
- Where
- Russia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biocad
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Trial name
- NCT04670796
- Testing
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Volunteer
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers.
- Trial name
- NCT01344863
- Testing
- trastuzumab [Herceptin]
- Where
- 2 sites in New Zealand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v.
- Trial name
- TROIKA-1 (NCT03776240)
- Testing
- HD201, EU-Herceptin, US-Herceptin
- Where
- Australia
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Prestige Biopharma Limited
Healthy
To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)
A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
- Trial name
- NCT06687928
- Testing
- CT-P6 SC, EU-Approved Herceptin SC
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy Volunteers
Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin)…
- Trial name
- NCT04049409
- Testing
- CMAB809, Trastuzumab
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Participants
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system…
- Trial name
- NCT07214766
- Testing
- Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg.
- Trial name
- NCT04175171
- Testing
- Coprelotamab Injection, Trastuzumab Injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
Identifying Patterns in the Breath of Individuals With Breast Cancer
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.
- Trial name
- NCT06512350
- Where
- 5 sites in United States, Canada
- Volunteers
- 5,175 people, healthy volunteers welcome
- Sponsor
- Breathe BioMedical Inc
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).
- Trial name
- NCT02581748
- Testing
- HLX02, Herceptin
- Where
- China
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech